Recommendations for biomarker identification and qualification in clinical proteomics

Harald Mischak; Günter Allmaier; Rolf Apweiler; Teresa Attwood; Marc Baumann; Ariela Benigni; Samuel E Bennett; Rainer Bischoff; Erik Bongcam-Rudloff; Giovambattista Capasso; Joshua J Coon; Patrick D'Haese; Anna F Dominiczak; Mohammed Dakna; Hassan Dihazi; Jochen H Ehrich; Patricia Fernandez-Llama; Danilo Fliser; Jorgen Frokiaer; Jerome Garin; Mark Girolami; William S Hancock; Marion Haubitz; Denis Hochstrasser; Rury R Holman; John P A Ioannidis; Joachim Jankowski; Bruce A Julian; Jon B Klein; Walter Kolch; Theo Luider; Ziad Massy; William B Mattes; Franck Molina; Bernard Monsarrat; Jan Novak; Karlheinz Peter; Peter Rossing; Marta Sánchez-Carbayo; Joost P Schanstra; O John Semmes; Goce Spasovski; Dan Theodorescu; Visith Thongboonkerd; Raymond Vanholder; Timothy D Veenstra; Eva Weissinger; Tadashi Yamamoto; Antonia Vlahou

doi:10.1126/scitranslmed.3001249

Recommendations for biomarker identification and qualification in clinical proteomics

Harald Mischak, Günter Allmaier, Rolf Apweiler, Teresa Attwood, Marc Baumann, Ariela Benigni, Samuel E Bennett, Rainer Bischoff, Erik Bongcam-Rudloff, Giovambattista Capasso, Joshua J Coon, Patrick D'Haese, Anna F Dominiczak, Mohammed Dakna, Hassan Dihazi, Jochen H Ehrich, Patricia Fernandez-Llama, Danilo Fliser, Jorgen Frokiaer, Jerome GarinMark Girolami, William S Hancock, Marion Haubitz, Denis Hochstrasser, Rury R Holman, John P A Ioannidis, Joachim Jankowski, Bruce A Julian, Jon B Klein, Walter Kolch, Theo Luider, Ziad Massy, William B Mattes, Franck Molina, Bernard Monsarrat, Jan Novak, Karlheinz Peter, Peter Rossing, Marta Sánchez-Carbayo, Joost P Schanstra, O John Semmes, Goce Spasovski, Dan Theodorescu, Visith Thongboonkerd, Raymond Vanholder, Timothy D Veenstra, Eva Weissinger, Tadashi Yamamoto, Antonia Vlahou

275 Citationer (Scopus)

Abstract

Clinical proteomics has yielded some early positive results-the identification of potential disease biomarkers-indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident that commonly encountered shortcomings in fundamental aspects of experimental design mainly during biomarker discovery must be addressed in order to provide robust data. In this Perspective, we assert that successful studies generally use suitable statistical approaches for biomarker definition and confirm results in independent test sets; in addition, we describe a brief set of practical and feasible recommendations that we have developed for investigators to properly identify and qualify proteomic biomarkers, which could also be used as reporting requirements. Such recommendations should help put proteomic biomarker discovery on the solid ground needed for turning the old promise into a new reality.

Originalsprog	Engelsk
Tidsskrift	Science translational medicine
Vol/bind	2
Udgave nummer	46
Sider (fra-til)	46ps42
ISSN	1946-6234
DOI	https://doi.org/10.1126/scitranslmed.3001249
Status	Udgivet - 25 aug. 2010
Udgivet eksternt	Ja

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10.1126/scitranslmed.3001249

Citationsformater

Mischak, H., Allmaier, G., Apweiler, R., Attwood, T., Baumann, M., Benigni, A., Bennett, S. E., Bischoff, R., Bongcam-Rudloff, E., Capasso, G., Coon, J. J., D'Haese, P., Dominiczak, A. F., Dakna, M., Dihazi, H., Ehrich, J. H., Fernandez-Llama, P., Fliser, D., Frokiaer, J., ... Vlahou, A. (2010). Recommendations for biomarker identification and qualification in clinical proteomics. Science translational medicine, 2(46), 46ps42. https://doi.org/10.1126/scitranslmed.3001249

Mischak, H, Allmaier, G, Apweiler, R, Attwood, T, Baumann, M, Benigni, A, Bennett, SE, Bischoff, R, Bongcam-Rudloff, E, Capasso, G, Coon, JJ, D'Haese, P, Dominiczak, AF, Dakna, M, Dihazi, H, Ehrich, JH, Fernandez-Llama, P, Fliser, D, Frokiaer, J, Garin, J, Girolami, M, Hancock, WS, Haubitz, M, Hochstrasser, D, Holman, RR, Ioannidis, JPA, Jankowski, J, Julian, BA, Klein, JB, Kolch, W, Luider, T, Massy, Z, Mattes, WB, Molina, F, Monsarrat, B, Novak, J, Peter, K, Rossing, P, Sánchez-Carbayo, M, Schanstra, JP, Semmes, OJ, Spasovski, G, Theodorescu, D, Thongboonkerd, V, Vanholder, R, Veenstra, TD, Weissinger, E, Yamamoto, T & Vlahou, A 2010, 'Recommendations for biomarker identification and qualification in clinical proteomics', Science translational medicine, bind 2, nr. 46, s. 46ps42. https://doi.org/10.1126/scitranslmed.3001249

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abstract = "Clinical proteomics has yielded some early positive results-the identification of potential disease biomarkers-indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident that commonly encountered shortcomings in fundamental aspects of experimental design mainly during biomarker discovery must be addressed in order to provide robust data. In this Perspective, we assert that successful studies generally use suitable statistical approaches for biomarker definition and confirm results in independent test sets; in addition, we describe a brief set of practical and feasible recommendations that we have developed for investigators to properly identify and qualify proteomic biomarkers, which could also be used as reporting requirements. Such recommendations should help put proteomic biomarker discovery on the solid ground needed for turning the old promise into a new reality.",

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T1 - Recommendations for biomarker identification and qualification in clinical proteomics

AU - Mischak, Harald

AU - Allmaier, Günter

AU - Apweiler, Rolf

AU - Attwood, Teresa

AU - Baumann, Marc

AU - Benigni, Ariela

AU - Bennett, Samuel E

AU - Bischoff, Rainer

AU - Bongcam-Rudloff, Erik

AU - Capasso, Giovambattista

AU - Coon, Joshua J

AU - D'Haese, Patrick

AU - Dominiczak, Anna F

AU - Dakna, Mohammed

AU - Dihazi, Hassan

AU - Ehrich, Jochen H

AU - Fernandez-Llama, Patricia

AU - Fliser, Danilo

AU - Frokiaer, Jorgen

AU - Garin, Jerome

AU - Girolami, Mark

AU - Hancock, William S

AU - Haubitz, Marion

AU - Hochstrasser, Denis

AU - Holman, Rury R

AU - Ioannidis, John P A

AU - Jankowski, Joachim

AU - Julian, Bruce A

AU - Klein, Jon B

AU - Kolch, Walter

AU - Luider, Theo

AU - Massy, Ziad

AU - Mattes, William B

AU - Molina, Franck

AU - Monsarrat, Bernard

AU - Novak, Jan

AU - Peter, Karlheinz

AU - Rossing, Peter

AU - Sánchez-Carbayo, Marta

AU - Schanstra, Joost P

AU - Semmes, O John

AU - Spasovski, Goce

AU - Theodorescu, Dan

AU - Thongboonkerd, Visith

AU - Vanholder, Raymond

AU - Veenstra, Timothy D

AU - Weissinger, Eva

AU - Yamamoto, Tadashi

AU - Vlahou, Antonia

PY - 2010/8/25

Y1 - 2010/8/25

N2 - Clinical proteomics has yielded some early positive results-the identification of potential disease biomarkers-indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident that commonly encountered shortcomings in fundamental aspects of experimental design mainly during biomarker discovery must be addressed in order to provide robust data. In this Perspective, we assert that successful studies generally use suitable statistical approaches for biomarker definition and confirm results in independent test sets; in addition, we describe a brief set of practical and feasible recommendations that we have developed for investigators to properly identify and qualify proteomic biomarkers, which could also be used as reporting requirements. Such recommendations should help put proteomic biomarker discovery on the solid ground needed for turning the old promise into a new reality.

AB - Clinical proteomics has yielded some early positive results-the identification of potential disease biomarkers-indicating the promise for this analytical approach to improve the current state of the art in clinical practice. However, the inability to verify some candidate molecules in subsequent studies has led to skepticism among many clinicians and regulatory bodies, and it has become evident that commonly encountered shortcomings in fundamental aspects of experimental design mainly during biomarker discovery must be addressed in order to provide robust data. In this Perspective, we assert that successful studies generally use suitable statistical approaches for biomarker definition and confirm results in independent test sets; in addition, we describe a brief set of practical and feasible recommendations that we have developed for investigators to properly identify and qualify proteomic biomarkers, which could also be used as reporting requirements. Such recommendations should help put proteomic biomarker discovery on the solid ground needed for turning the old promise into a new reality.

KW - Biomarkers

KW - Humans

KW - Mass Spectrometry

KW - Proteomics

KW - Journal Article

KW - Research Support, N.I.H., Extramural

KW - Research Support, Non-U.S. Gov't

U2 - 10.1126/scitranslmed.3001249

DO - 10.1126/scitranslmed.3001249

M3 - Journal article

C2 - 20739680

SN - 1946-6234

VL - 2

SP - 46ps42

JO - Science translational medicine

JF - Science translational medicine

IS - 46

ER -

Recommendations for biomarker identification and qualification in clinical proteomics

Abstract

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